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The effect of aromatherapy with extract salix aegyptiaca on hypertension and quality of sleeping elderly referring to selected health centers of rafsanjan city at 2019

Protocol summary

Study aim
The effect of aromatherapy with extract salix aegyptiaca on hypertension and quality of sleeping elderly
Design
Two arm parallel-group randomized trial with blinded and outcome assessment. hypertension and quality of sleeping elderly will be measured in intervention and control group.
Settings and conduct
This study is a randomized, double blind clinical trial performed.One day before the intervention, the blood pressure of the elderly is measured with a Mercury blood pressure device and Their sleep quality by the Pittsburgh Questionnaire. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays). Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again.
Participants/Inclusion and exclusion criteria
Being 60 years old or olde, The fact that hypertension is detected by Diagnosis of the treating physician and available medical records, Having primary blood pressure Having a sleep disorder based on a score above 5 in the Pittsburgh Questionnaire, Healthy feeling, Not having sensitivity to the extract salix aegyptiaca, Not having sensitivity to the aromatic substances, Not having a history of allergies or respiratory diseases
Intervention groups
In the intervention group, the extract salix aegyptiaca is diluted. The elderly in the intervention group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation. Control group: In the control group, will be used a placebo.
Main outcome variables
hypertension and quality of sleeping

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150519022320N23
Registration date: 2020-08-08, 1399/05/18
Registration timing: retrospective

Last update: 2020-08-08, 1399/05/18
Update count: 0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-11, 1399/03/22
Expected recruitment end date
2020-07-02, 1399/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with extract salix aegyptiaca on hypertension and quality of sleeping elderly referring to selected health centers of rafsanjan city at 2019
Public title
The effect of aromatherapy with extract salix aegyptiaca on hypertension and quality of sleeping elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 60 years old or older, The fact that hypertension is detected by Diagnosis of the treating physician and available medical records, Having primary blood pressure, Having a sleep disorder based on a score above 5 in the Pittsburgh Questionnaire, Not having sensitivity to the extract salix aegyptiaca, Not having sensitivity to the aromatic substances, Not having a history of allergies or respiratory diseases, Healthy sense of smell
Exclusion criteria:
Age
From 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
according to the simple randomization, patients were divided into 35 groups, the intervention group and the control group. Patients were divided into two groups of 35 people, A and B, based on a table of random numbers, and finally, groups A and B were divided into intervention and control groups based on the lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researcher colleague do not aware of the type of group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences ethics committee
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.RUMS.REC.1398.209

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
IX 110
ICD-10 code description
Essential (primary) hypertension Incl.: High blood pressure

2

Description of health condition studied
Sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
hypertension
Timepoint
Before the intervention, 2,5,9,12 days after, two days after intervention
Method of measurement
Blood pressure in millimetres of mercury using a Mercury blood pressure

2

Description
Sleep quality
Timepoint
sleep quality measured in control and intervention groups (before and after the intervention) using the Pittsburgh Sleep Quality Index.
Method of measurement
the Pittsburgh Sleep Quality Index.

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, the extract salix aegyptiaca produced in exir hayat Company with a concentration of 20% is used. The elderly in the intervention group are given a dropper containing extract salix aegyptiaca for two weeks. The elderly in the intervention group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation. One day before the intervention, the elderly are explained exactly how to do the plan and the consent form is completed by the elderly and on the same day their blood pressure is measured with a mercury blood pressure monitor and their sleep quality is measured with the Pittsburgh questionnaire..To prevent forgetting the aromatherapy sessions, it is recommended that the elderly perform aromatherapy when performing the morning and evening prayers (morning and evening). Elderly people are asked to take medications for high blood pressure and insomnia within two weeks of the intervention at specific times so that the time of medication does not affect blood pressure and sleep quality. Also, standard conditions for controlling blood pressure include ten minutes of rest before taking blood pressure, inactive physical activity before going to the health center, empty bladder, sitting position evenly and placing the hand on the level of the heart. These cases are registered in the blood pressure registration form before taking the blood pressure. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again. To ensure extract consumption, the exact checklist for aromatherapy is completed by the elderly and delivered to the researcher.
Category
Treatment - Other

2

Description
Control group: In the control group, water will be used as a placebo.In the control group, the dropper head is impregnated with extract salix aegyptiaca to disperse some of the smell in the space when opened. This is done in order to continue the cooperation of the elderly in the control group and not to realize that they have a placebo. The elderly in the control group also Will be asked to undergo aromatherapy for 2 minutes twice a day for 2 weeks by inhaling three drops of placebo on cotton at a distance of 5 cm from the nose. In the control group also one day before the intervention, the elderly are explained exactly how to do the plan and the consent form is completed by the elderly and on the same day their blood pressure is measured with a mercury blood pressure monitor and their sleep quality is measured with the Pittsburgh questionnaire. To prevent forgetting the aromatherapy sessions, it is recommended that the elderly perform aromatherapy when performing the morning and evening prayers (morning and evening). Elderly people are asked to take medications for high blood pressure and insomnia within two weeks of the intervention at specific times so that the time of medication does not affect blood pressure and sleep quality. Also, standard conditions for controlling blood pressure include ten minutes of rest before taking blood pressure, inactive physical activity before going to the health center, empty bladder, sitting position evenly and placing the hand on the level of the heart. These cases are registered in the blood pressure registration form before taking the blood pressure.. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again. To ensure plasebo consumption, the exact checklist for aromatherapy is completed by the elderly and delivered to the researcher.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 3 Rafsanjan
Full name of responsible person
Elham Alinejad
Street address
Rafsanjan, West Shariati St., Health Center, No. 3
City
Rafsanjan
Province
Kerman
Postal code
7772625555
Phone
+98 34 3342 4827
Email
e.alinejad034@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Shamsizade Ali
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3452 5900
Email
t.mirzaei@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Email
t.mirzaei@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Associate Professor, School of Nursing and Midwifery, Rafsanjan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34255900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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